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Automation Engineer. Job in Durham FOX8 Jobs

Location
Durham, North Carolina
Job Type
Permanent
Posted
10 Jun 2022

General Company Description

Resilience (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients' lives.

For more information, visit .

Position Summary & Role (general description of the role; e.g. expectations, key milestones, impact)

Join Resilience's enthusiastic and collaborative team by contributing to the overall success of our novel gene and cell therapy approach in our new vector manufacturing facility in North Carolina's Research Triangle.

As an Automation Engineer you will have detailed knowledge of or experience with GMP processing and manufacturing, data historians, OPC, PLCs and associated coding methods, field instrumentation and control system expertise.

Job Responsibilities (core responsibilities; include people management if applicable)

  • Provide day-to-day engineering support for on-going manufacturing systems including Rockwell FactoryTalk products, Unicorn, Sartorius, and OSI Pi.
  • Provide technical support and troubleshooting for automation systems, projects and instrumentation hardware.
  • Partner with automation system service providers, contract resources and Instrument/Electrical technicians ensuring safe, compliant maintenance and project execution.
  • Support automation issue identification and resolution, including all compliance aspects such as Deviation investigation, Change Control, Corrective and Preventative Action (CAPA).

Requirements

  • Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations, including being on-call for after-hours remote support as required.
  • Support configuration, administration and maintenance activities of the sites manufacturing computer and automation systems, including process control systems.
  • Ability to evaluate automation systems from a compliance perspective and ensure adherence to applicable standards (i.e. GAMP, 21CFR Part 11, EU Annex 11)
  • Troubleshooting experience, both hardware and software, at a 24x7 manufacturing cGMP operation.

Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)

  • Requires a BS/MS in Engineering or related field
  • 7+ years of experience inthe automation discipline in a regulated manufacturing environment.
  • Strong understanding of cGMPs and good engineering practice (GEP), including ISA S88, GAMP, ASTM E2500, ISPE guidance, etc.
  • Experience with Unicorn.
  • Experience with Sartorius.
  • Experience with HMI/SCADA packages such as: Rockwell RSView, FactoryTalk.
  • Experience with OSI PI / OPC.
  • Experience with PLCs such as: Rockwell, Siemens.
  • Experience in plant start up, equipment commissioning, and qualification is a plus.

Other Ideal Personal Characteristics:

  • A passion for addressing the critical unmet medical needs of patients.
  • Self-directed individual whois able towork with limited direction in a fast-paced, goal-oriented environment.
  • Willingness to embrace and demonstrate the principles of the Resilience phenotypes: Resilience + Grit, Velocity, Service-orientation, EQ + IQ, Builder Mentality, Quality + Rigor, Ownership.

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Details

  • Job Reference: 620982401-2
  • Date Posted: 10 June 2022
  • Recruiter: Resilience
  • Location: Durham, North Carolina
  • Salary: On Application
  • Sector: Engineering
  • Job Type: Permanent